Comparative efficacy and safety of nimesulide and diclofenac in patients with acute shoulder, and a meta-analysis of controlled studies with nimesulide.

Adverse events, particularly gastrointestinal, partially offset the therapeutic value of NSAIDs. The abilities of nimesulide to inhibit COX-2 preferentially and to exert other novel anti-inflammatory actions are consistent with good efficacy and safety. This is borne out by a double-blind multicentre comparison of nimesulide and diclofenac in 122 patients with acute shoulder, and by a meta-analysis of various nimesulide trials. At the end of the 14 day double-blind study, nimesulide was at least as effective as diclofenac (investigator ratings: good/very good in 79.0% of patients given nimesulide, and 78.0% with diclofenac; patient ratings: good/very good in 82.3 and 78.0% respectively). Four patients (6.5%) dropped out in the nimesulide group (two early recovery, one lack of effect, one adverse event), compared with 13 (21.7%) in the diclofenac group, due mainly to adverse events (P=0.003). Global tolerability was judged by the investigators to be good/very good in 96.8% of the nimesulide group compared with 72.9% of those given diclofenac. Judgements by the patients were 96.8 and 78.0% respectively. Both differences are highly significant statistically. The meta-analysis demonstrates that nimesulide given for 2 weeks is far more efficacious than placebo in treating osteoarthritis, and is at least comparable to other NSAIDs The benefit-risk ratio for nimesulide was better in all individual studies since 100 mg nimesulide twice daily was about equal to placebo in safety and tolerability, especially regarding gastrointestinal adverse events.

RCT Entities:   Population Interventions Outcomes